Pharma II - Drug Development and Regulation

Course content

The topics taught are:

  • Preclinical efficacy tests in animal models
  • Clinical trials
  • Regulatory affairs
  • Quality assurance
  • Production and marketing
Education

BRIDGE - Translational Excellence Programme

 

Learning outcome

On completion of the course, the participants should be able to:

Knowledge
•    Give a comprehensive overview of the preclinical efficacy tests in animals and clinical phase of development of medicines
•    Identify correct professional terms in clinical development of medicines
•    List major steps and elements of the preclinical efficacy tests in animals and clinical drug development process
•    Outline definitions of key concepts and the fundamentals of the major disciplines in clinical development
•    Identify the important transition points that require involvement of authorities

Skills
•    Appraise the integration of the various basic disciplines into the process of preclinical efficacy tests in animals and clinical development of medicines
•    Analyse the sequence and flow of the various steps in the process of clinical drug discovery and development
•    Plan a development process within the regulatory framework

Competences
•    Liaise with all steps of clinical drug development
•    Identify critical factors and bottlenecks that influence the preclinical efficacy tests in animals and clinical drug development process
•    Promote and state milestones for the progress of the clinical development of a medical product
•    Communicate professionally with the various specialist groups within the area of development of medicines

The course is organized as an intensive 5-day course and comprises lectures, group discussions, case studies, presentations and discussions

The syllabus comprises collections of review papers, textbook chapters and case stories and updated lecture slides. 

Participants are expected to purchase: Drug Discovery and Development. Technology in Transition, 2nd edition Humphrey P. Rang, Churchill Livingstone, 978-0443064203. Avalable also as E-Book.

The Textbook of Pharmaceutical Medicine, 7th edition, 2013. John P. Griffin (Editor), John Posner (Editor), Geoffrey R. Barker (Editor) Blackwell BMJ Books serves as “nice to know”.

Participants must meet the admission criteria in BRIDGE - Translational Excellence Programme

Oral
Continuous feedback during the course of the semester
ECTS
0 ECTS
Type of assessment
Continuous assessment
Course participation
Attendance and active participation
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

Attendance and active participation

Part time Master and Diploma courses

  • Category
  • Hours
  • Lectures
  • 20
  • Theory exercises
  • 15
  • English
  • 35